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510(k) K121250

OP SPINE SYSTEM by OrthoPediatrics Corp. — Product Code OSH

K121250 is an FDA 510(k) premarket notification submitted by OrthoPediatrics Corp. for the device "OP SPINE SYSTEM". The FDA issued a decision of SESU on June 19, 2012. The device falls under product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis), a Class II device regulated under 21 CFR 888.3070. OrthoPediatrics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
June 19, 2012
Date Received
April 25, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

Other clearances by OrthoPediatrics Corp.

  • K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System (April 30, 2026)
  • K252600 — Pediatric Plating Platform I Small-Mini (October 9, 2025)
  • K251362 — PediFlex™ Flexible Nail System (June 24, 2025)
  • K243963 — Pediatric Plating Platform Hip (April 29, 2025)
  • K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (April 1, 2025)
  • K241816 — VerteGlide Spinal Growth Guidance System (March 14, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)
  • K233105 — RESPONSE™ Rib and Pelvic System (January 20, 2024)
  • K231266 — Pediatric Nailing Platform Tibia (August 21, 2023)
  • K222105 — RESPONSE 5.5/6.0 Cannulated Screw System (March 23, 2023)

Other clearances for product code OSH

  • K153446 — OLYMPIC Posterior Spinal Fixation System (April 8, 2016)
  • K140276 — CD HORIZON SPINAL SYSTEM (March 13, 2014)
  • K132574 — PASS LP SPINAL SYSTEM (November 8, 2013)
  • K132303 — IMPLANET SPINE SYSTEM (October 10, 2013)
  • K132575 — PASS LP SPINAL SYSTEM (October 3, 2013)
  • K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (September 12, 2013)
  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K131784 — RANGE SPINAL SYSTEM (August 30, 2013)
  • K131321 — CD HORIZON SPINAL SYSTEM (June 5, 2013)
  • K124058 — CREO STABILIZATION SYSTEM (May 13, 2013)

FDA data resources